Phase 2
Completed N=28
Mild Encephalopathy in the Newborn Treated With Darbepoetin
Neonatal encephalopathy · Hypoxic-Ischemic Encephalopathy Mild
Source: ClinicalTrials.gov NCT03071861 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Normal Neurodevelopment — 13; 14 Participants
Summary
This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normal Neurodevelopment |
13; 14 | — |
| SECONDARY Percent of Infants With Adverse Events |
0; 0 | — |
| SECONDARY Percent of Infants With Seizures |
0; 0 | — |
| SECONDARY Percentage of Infants Who Need Gavage Feeds or Gastrostomy at Discharge Home |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational age > 34 weeks by best obstetric estimate, are 65%, platelet count >600,000/dL, and/or neutropenia (ANC<500 μL)
- ECMO
- Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Data sourced from ClinicalTrials.gov (NCT03071861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.